An open-labeled, randomized, two-dose, parallel group trial of ofatumumab, a fully human monoclonal anti-CD20 antibody, in combination with fludarabine and cyclophosphamide, in patients with previously untreated B-cell Chronic Lymphocytic Leukemia - Ofatumumab with fludarabine and cyclophosphamide in B-CLL patients
- Conditions
- B-cell Chronic Lymphocytic LeukemiaMedDRA version: 9.1 Level: LLT Classification code 10008958 Term: Chronic lymphocytic leukaemia
- Registration Number
- EUCTR2007-000243-10-GB
- Lead Sponsor
- Glaxo SmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Patients with active B-CLL and with an indication for treatment, defined as presenting one of the following conditions defined by NCIWG guidelines:
a. any one of the following disease related conditions:
i. 10% or greater weight loss within the previous six months, or
ii. fevers = 100.5°F (38.0°C) for = 2 weeks without evidence of infection, or
iii. night sweats without evidence of infection;
b. evidence of progressive marrow failure as manifested by development of, worsening of anemia or thrombocytopenia; or
c. massive (= 6 cm below the left costal margin) or progressive splenomegaly; or
d. massive nodal clusters (= 10 cm in longest diameter) or progressive lymphadenopathy; or
e. progressive lymphocytosis with an increase or > 50% over a two month period or an anticipated doubling time < 6 months
2) Circulating lymphocytes > 5 x 10^9/L at screening blood sample
3) Flow cytometry evidence of CD5, CD20, CD23 positive lymphocytes
4) Age = 18 years
5) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Any previous treatment for B-CLL or any other treatments that can be considered active against B-CLL
2) Glucocorticoid unless given in doses = 10 mg /day for other indications than B-CLL (e.g. asthma)
3) Known transformation of B-CLL
4) Known CNS involvement of B-CLL
5) Past or current malignancy, except for:
a. Cervical carcinoma Stage 1B or less
b. Non-invasive basal cell and squamous cell skin carcinoma
c. Malignant melanoma with a complete response of a duration of > 10 years
d. Other cancer diagnoses with a complete response of a duration of > 5 years
6) Chronic or current infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
7) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
8) Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
9) History of significant cerebrovascular disease
10) Known HIV positive
11) Positive serology for hepatitis B, unless due to vaccination
12) Screening laboratory values
a. creatinine > 1.5 times upper normal limit (unless normal creatinine clearance)
b. total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of B-CLL)
c. ALT > 2.5 times upper normal limit (unless due to liver involvement of B-CLL)
13) Known or suspected hypersensitivity to components of investigational product
14) Leukapheresis except as a safety measure before immunochemotherapy
15) ECOG Performance Status of 3 or 4
16) Patients who at the time of inclusion are not expected to be able to complete the ofatumumab-FC regimen
17) Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 1
18) Current participation in any other interventional clinical study
19) Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
20) Breast feeding women or women with a positive pregnancy test at Visit 1
21) Women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method